WO2006055046A2 - Procédé et système assurant une chaîne de traçabilité électronique - Google Patents

Procédé et système assurant une chaîne de traçabilité électronique Download PDF

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Publication number
WO2006055046A2
WO2006055046A2 PCT/US2005/021328 US2005021328W WO2006055046A2 WO 2006055046 A2 WO2006055046 A2 WO 2006055046A2 US 2005021328 W US2005021328 W US 2005021328W WO 2006055046 A2 WO2006055046 A2 WO 2006055046A2
Authority
WO
WIPO (PCT)
Prior art keywords
item
custodian
electronic form
information
custody
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2005/021328
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English (en)
Other versions
WO2006055046A3 (fr
Inventor
Peter Spellman
Shabbir Dahod
Lucia Deus
Craig Leckband
Sean Wellington
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SupplyScape Corp
Original Assignee
SupplyScape Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by SupplyScape Corp filed Critical SupplyScape Corp
Publication of WO2006055046A2 publication Critical patent/WO2006055046A2/fr
Publication of WO2006055046A3 publication Critical patent/WO2006055046A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • G—PHYSICS
    • G06—COMPUTING OR CALCULATING; COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L9/00—Cryptographic mechanisms or cryptographic arrangements for secret or secure communications; Network security protocols
    • H04L9/32—Cryptographic mechanisms or cryptographic arrangements for secret or secure communications; Network security protocols including means for verifying the identity or authority of a user of the system or for message authentication, e.g. authorization, entity authentication, data integrity or data verification, non-repudiation, key authentication or verification of credentials
    • H04L9/3247—Cryptographic mechanisms or cryptographic arrangements for secret or secure communications; Network security protocols including means for verifying the identity or authority of a user of the system or for message authentication, e.g. authorization, entity authentication, data integrity or data verification, non-repudiation, key authentication or verification of credentials involving digital signatures
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L2209/00—Additional information or applications relating to cryptographic mechanisms or cryptographic arrangements for secret or secure communication H04L9/00
    • H04L2209/56—Financial cryptography, e.g. electronic payment or e-cash
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L2209/00—Additional information or applications relating to cryptographic mechanisms or cryptographic arrangements for secret or secure communication H04L9/00
    • H04L2209/80—Wireless
    • H04L2209/805—Lightweight hardware, e.g. radio-frequency identification [RFID] or sensor
    • H—ELECTRICITY
    • H04—ELECTRIC COMMUNICATION TECHNIQUE
    • H04L—TRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L2209/00—Additional information or applications relating to cryptographic mechanisms or cryptographic arrangements for secret or secure communication H04L9/00
    • H04L2209/88—Medical equipments

Definitions

  • the present invention relates generally to maintaining a chain of custody record for the handling of physical items and, more particularly, to an electronic chain of custody record that provides a verifiable record of item handling.
  • Chain of custody records can be used for tracking and tracing the movement of an item in a supply chain, and for authenticating the item as it is transferred in the chain.
  • a system that can accurately maintain chain of custody records can be particularly useful to inhibit the distribution of counterfeit products in the supply chain.
  • the present invention is generally directed to methods and systems for maintaining a chain of custody record for the handling of an item transferred among a plurality of custodians, e.g., in a product supply chain.
  • an electronic form that can be transferred from custodian to custodian provides a record of the chain of custody.
  • the form can be successively transferred from a computer operated by one custodian to a computer operated by another corresponding to the successive transfer of the item from the custodian to the other.
  • the form identifies the item that is transferred and includes space for entry of information by each custodian handling the item.
  • the information entered by the custodians includes an identification of the custodian and a digital signature of the custodian authenticating the item. At least some of the information entered by a custodian is unalterable by another custodian receiving the form.
  • FIGURE 1 is a simplified block diagram illustrating an exemplary supply chain in the pharmaceutical industry
  • FIGURE 2 is a simplified block diagram generally illustrating the process of maintaining a chain of custody record for the handling of a drug product in accordance with one or more embodiments of the invention.
  • FIGURE 3 is a screen shot of an exemplary electronic form in accordance with one or more embodiments of the invention.
  • the present invention is generally directed to methods and systems for maintaining electronic, certified chain of custody records for physical items or articles like products, materials or objects.
  • the term "item” is broadly used herein to include single or multiple products, materials, or objects.
  • the certified chain of custody is in the form of a transferable electronic document or file that provides a verifiable record of the chain of custody for the handling of the item.
  • the electronic document or file can reside on and is successively transferable among computer systems operable by custodians of the items.
  • the chain of custody file references items in the physical world, which are linked to the chain of custody file by unique identifiers such as, e.g., serial numbers.
  • the serial number or other identifier can be indicated or stored on the item itself or on a container or packaging for the item and can be read by visual inspection or using various sensing mechanisms including bar code readers and Radio Frequency Identification (RFID) systems and other automatic data capture technologies.
  • RFID Radio Frequency Identification
  • the chain of custody file contains information about the item referenced. This information can be used to help identify or verify (i.e., authenticate) the item or to provide computer systems processing the chain of custody more information about the item.
  • the chain of custody file can contain information about the context of the change in custody. This information can include who the custodians are, their organizations and roles, date /time, reason for the change in custody and other information pertinent to the change of custody (including, e.g., whether it is a sale, transfer, return etc.). Depending on the chain of custody scenario, this information can vary from application to application as desired.
  • the chain of custody file can be certified using digital signatures.
  • Each custodian successively signs the entire chain of custody file (verifying, e.g., item information, information about the context of each change in custody), including the previous custodians' information.
  • no part of the chain of custody file can be modified or substituted by subsequent parties.
  • Custodians can certify the chain of custody file by digitally signing it when the item leaves their custody.
  • custodians can optionally also certify the chain of custody by digitally signing it when associated items come into their custody.
  • the chain of custody file can also include references to the business documentation for changes in custody as part of the context of change of custody, which may be used to get more detailed information on the transaction from other sources or systems (e.g., an invoice number).
  • the chain of custody file is a document-based electronic form.
  • the document can be routed (either using, e.g., computers on a network or removable media) successively from custodian to custodian for processing, enabling each custodian to have their own document of record for the chain of custody, secured by the digital signatures.
  • networks that can be used to transfer the form include the Internet, Intranets, LANs, WANs, and other computer networks.
  • a copy of the chain of custody document can also be sent to interested parties and /or to a central authority for processing or monitoring.
  • the chain of custody file can be validated at any time by processing the digital signatures. This ensures that the chain of custody file is valid at any time, and especially at the time of a change in custody (when new digital signatures are being added).
  • the chain of custody document prior to receipt of the item or items referenced in the chain of custody, can be sent to the recipient and verified electronically to ensure its validity up to the point of their receipt.
  • a chain of custody file can be created at any time where the custodial history must be maintained. This could be, e.g., when the item is manufactured or when the item comes into an environment requiring that the chain of custody be maintained.
  • the chain of custody file is maintainable and verifiable within and across organizations.
  • Each custodian can retain a copy of the chain of custody file for his or her own records.
  • the custodian can be, e.g., an individual, role or organization.
  • the level of accountability can be influenced by the granularity of the custodian, e.g., individuals are generally more accountable than roles.
  • disposition of item for the change of custody (what the item referenced by the chain of custody is intended to be used for) can also be included, providing preferably an unalterable record of the purpose for which the item is changing custody. This can be used to help ensure that the item is handled appropriately. For example, if an item is changing hands to be destroyed or recycled, then that disposition can be expressed in the chain of custody. Systems processing the chain of custody can use that information to help comply with the disposition and subsequent attempts to use that chain of custody will show that the item was intended for destruction or recycling and therefore should not be used for another purpose.
  • a chain of custody system in accordance with one or more embodiments of the invention can have a variety of applications including, but not limited to, use in the pharmaceutical, food, defense, medical devices, electronics, software and music industries, and in maintaining homeland security and controlling imports.
  • Use of a chain of custody system in accordance with one or more embodiments of the invention in the pharmaceutical industry can streamline secure drug delivery cost-effectively and enable rapid authentication, serialized drug tracking, cost-effective pedigree tracing, precision recalls and reimbursement compliance.
  • EPC Electronic Product Code
  • the EPC or other serialization can be implemented along with a tracking mechanism such as, e.g., radio frequency identification technology (RFID), which can efficiently track drugs during shipping and receiving without manual scanning.
  • RFID radio frequency identification technology
  • the chain of custody system provides a secure, authentic, electronic chain of custody for each item to help safeguard the drug supply chain against counterfeits.
  • the chain of custody system can link to product databases providing details for physical authentication of each unique drug product, thereby increasing drug control and safety, while protecting the brand of a drug manufacturer.
  • the system can electronically track the drug's movement in the open supply chain from one custodian to the next.
  • the chain of custody system also provides a rapid and accurate trace of all the custodians of the drug, which can significantly reduce time for making a recall, e.g., from weeks to hours.
  • the chain of custody system thereby provides an "electronic pedigree" for an item that significantly decreases the potential of a wholesaler or pharmacist to receive counterfeit drugs.
  • the pharmaceutical supply chain can cost effectively implement more effective pedigrees for drug products.
  • RFID technology can improve accuracy in receiving and shipping operations, while decreasing labor time and costs for recalls and returns.
  • the system can provide brand value protection, reduced shrink (i.e., inventory losses), more precise recalls at lower cost, and more accurate returns and reimbursements. The result is a safer drug supply chain that is also more cost- effective and time-efficient.
  • FIGURE 1 A simplified example of a supply chain is shown in FIGURE 1.
  • a direct distribution path is shown at unshaded blocks 10-18.
  • Points of entry to the chain of potential counterfeit drugs are shown in the shaded blocks 20-30.
  • Produced in bulk by the manufacturer, many drugs are repackaged into manageable quantities by authorized wholesalers and repackagers before shipment to retail pharmacies and health care institutions.
  • a drug may pass through numerous secondary wholesalers and distributors (sometimes as many as eight or ten) before reaching the pharmacist who dispenses it to the consumer.
  • Many entities provide legitimate services such as closed door pharmacies who supply deeply discounted drugs to Medicaid and hospice patients.
  • unscrupulous wholesalers or repackagers 20 may combine counterfeit with authentic drugs.
  • pharmacies provide pharmaceuticals to a selected audience, such as HTV/ AIDS patients or the elderly. These are called “closed door pharmacies" 26. While many closed door pharmacies lawfully sell deeply discounted drugs to patients in hospices and nursing homes, others divert the drugs at full price to secondary wholesalers. Diversion is also a way for diluted or adulterated drugs to enter the legitimate drug supply. [0034] When counterfeit drugs find their way into the legitimate distribution chain, they endanger patients and impact the whole industry. Pharmaceutical manufacturers lose millions when counterfeiting tarnishes the reputation of a trusted brand, and when their authentic drugs are diverted by profiteers. At the receiving end of the drug supply chain, retail, institutional and Internet pharmacies are concerned with providing safe drugs to their patients.
  • an EPC serial number is stored on an RFID tag, which is a tiny computer chip, and the EPC /RFID tag is attached to each drug product unit. This makes it possible to easily track every individual drug unit as it moves through the supply chain.
  • FIGURE 2 shows how a chain of custody system in accordance with one or more embodiments of the invention can be used to track each drug.
  • the electronic pedigree grows as each successive custodian's information on its handling of the product is added.
  • Each custodian signs the pedigree, creating an ever-growing record of each transaction that is trusted and secure.
  • digital signature technology can be used to authenticate and retrieve information and secure data encryption via the Secure Sockets Layer (SSL) protocol standard.
  • SSL Secure Sockets Layer
  • the new custodian should authenticate the drug, its EPC serial number, and its custodian history, or pedigree.
  • the authentication process includes verifying the drug is in fact what was ordered and also confirming the anti-counterfeit and tamper-evident measures.
  • the authentication and pedigree tracking process may occur when the products are received. Sellers may be required to provide the authentication and pedigree details about each drug product in advance, which gives the receiving custodian time to check the pedigree and EPC for each drug before the transaction. [0039] As shown in FIGURE 2, the drug manufacturer 50 can pre-position advance pedigree information 57 and EPCs to be expected on the electronic form 70 and forward the form 70 to wholesaler 52.
  • Wholesaler 52 can authenticate the electronic form 70 and EPC that it describes prior to receiving the item.
  • the manufacturer 50 receives confirmation of authentication and ships the item to the wholesaler 52. (It should be noted that this confirmation need not be a precondition to the shipping.)
  • the wholesaler 52 adds details to the form as indicated by added section 58 of the form.
  • the wholesaler 52 can pre-position advance pedigrees for a combination of products, and then ship to wholesaler 54.
  • the drug item eventually reaches a retail pharmacist 56, whose details are added to the pedigree as indicated by added section 62 of the form.
  • the pharmacist can track the scripts dispensed to each customer and retain the association with the EPC serial number.
  • the electronic pedigree In the event of a recall or counterfeit incident, the electronic pedigree identifies all prior transactions and custodians of this drug product unit, enabling rapid investigation of potential points of compromise. A drug information trace is shown, e.g., along the dashed arrows in FIGURE 2.
  • the electronic pedigree trace of each serialized EPC can provide regulators with a robust analysis tool to quickly identify potential vulnerability points and alert affected custodians - wholesalers, pharmacists and consumers. If a trace indicates the problem occurred at a specific custodian, then the FDA could notify all owners of other drugs handled by that custodian in the same timeframe and/or by the same worker.
  • the tracing process in accordance with one or more embodiments of the invention can help authorities quickly notify with pinpoint accuracy the custodians and consumers who may be affected, while avoiding alarming the general public.
  • the recall timeframe can be significantly reduced, e.g., from weeks to hours.
  • FIGURE 3 is an exemplary screenshot of an electronic pedigree in accordance with one or more embodiments of the invention.
  • the electronic pedigree serializes each drug product to provide identity authentication based preferably on the EPC standard as indicated at 80.
  • the Electronic Pedigree can include an "Anti-counterfeit measures" link 82 to product databases on a network providing details for physical authentication of each unique drug product, thereby increasing drug control and safety while protecting the brand.
  • Physical authentication can include overt and covert anti-counterfeit and anti-tamper measures.
  • the electronic pedigree can track the drug's movement from one custodian to the next using information on the custodians as indicated, e.g., at 84.
  • the electronic pedigree can provide a rapid and accurate trace of all the custodians of the drug. Tracing this drug's custodians enables public safety authorities to quickly identify other drug products that may be similarly affected.
  • the electronic pedigree enables drug authentication, drug tracking, and drug tracing in an open supply chain preferably using the EPC standard.
  • the robust pedigree application enables two-way information analysis for tracking the drug product as it moves forward in the supply chain, and for tracing a return, recall, or counterfeit investigation back to the source, regardless of where it occurs between the manufacturer and the consumer.
  • overt authentication measures e.g., the anti counterfeit measures link 82
  • EPCs Electronic Pedigree for rapid access. Even when authentication measures are changed to thwart counterfeiters, drugs with former authentication measures can still be verified since the electronic pedigree EPC can provide association to the historical information.
  • the electronic pedigree can track the parent/child genealogy. Because bulk repackagers typically change the package, new EPC serial numbers are assigned for each new package. The bulk EPC can be retired, but information about this bulk EPC is retained for track and trace purposes.
  • Repackaging can be tracked regardless of where it occurs - at the pharmacy, wholesaler, repackager, or manufacturer.
  • the electronic pedigree can make it possible to trace a drug from the point of dispensation all the way back to bulk manufacturing. In the event of a recall or counterfeit incident, if the trace indicates the problem occurred during repackaging, then authorities could notify all owners of drugs repackaged from the same parent EPC, or if warranted, different drugs repackaged at the same facility in the same timeframe.
  • the chain of custody system can authenticate the EPC identity of every drug product and can alert the shipping/receiving worker to exceptions based on each company's own business rules and operating procedures.
  • the chain of custody system can streamline receiving via the Advance Pedigree Notice, which the shipping custodian sends in advance.
  • the receiving entity analyzes and authenticates the drug pedigrees in the Advance Pedigree Notice before approving shipment. Then, when the drugs arrive in receiving, the EPCs on the drugs are verified against the Advance Pedigree Notice. Discrepancies can be flagged immediately.
  • a chain of custody system in accordance with one or more embodiments of the invention can provide secure and cost-effective mass serialization and tracking of animals, premises, and food products.
  • the chain of custody system can provide precise and rapid traceability through the food chain.
  • a chain of custody system in accordance with one or more embodiments of the invention can expedite cargo clearance and reduce examinations needed by U.S. Customs, while increasing cargo security and visibility as required by Customs Trade Partnership against Terrorism (C-TPAT), Free and Secure Trade Program (FAST), and Required Advance Electronic Presentation of Cargo Information.
  • a chain of custody system can precisely track cargo from manufacturer to customs inspection, and enable companies to cost- effectively provide detailed electronic records to Customs demonstrating cargo security prior to and during shipment and increases supply chain security against terrorism and unmanifested material.
  • a chain of custody system in accordance with one or more embodiments of the invention can enable the U.S. Department of Defense and its suppliers to quickly and efficiently process large volumes of serialized materiel and supplies, freeing personnel for reassignment and streamlining DoD business processes. It can enable rapid and accurate tracking of the life history of each asset - each part as well as the vehicles and equipment awaiting the parts. With this information, the DoD can automatically and accurately track repairs and usage histories including knowing the duration and under what conditions the equipment has been utilized.
  • a chain of custody system in accordance with one or more embodiments of the invention can be used for the tracking of medical devices and supplies. Precise tracking is important for rapid and cost-effective provision, reverse logistics, replenishment and accurate settlement of vendor managed inventory (VMI), consignment and kitting. Government regulations can require precise tracking of product expiration dates.
  • a chain of custody system in accordance with one or more embodiments of the invention can enable manufacturers and wholesale distributors to provide health care institutions with the right medical devices and supplies at the right locations at the right time.
  • a chain of custody system in accordance with one or more embodiments of the invention can be used in the electronics, software and music industries for authenticating and tracing high-value products with small footprints to reduce losses from counterfeiting, grey market, shrinkage and inappropriate returns.
  • the chain of custody system can reduce the cost and complexity of managing inventory comprised of multiple product versions and components that typically characterize the electronics and software industries.
  • the chain of custody system in accordance with various embodiments of the invention is preferably implemented in software. Accordingly, one of the preferred implementations of the invention is as a set of instructions (program code) in a code module resident in the random access memory of a computer. Until required by the computer, the set of instructions may be stored in another computer memory, e.g., in a hard disk drive, or in a removable memory such as an optical disk (for eventual use in a CD ROM) or floppy disk (for eventual use in a floppy disk drive), or downloaded via the Internet or some other computer network.
  • program code program code
  • the set of instructions may be stored in another computer memory, e.g., in a hard disk drive, or in a removable memory such as an optical disk (for eventual use in a CD ROM) or floppy disk (for eventual use in a floppy disk drive), or downloaded via the Internet or some other computer network.

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Abstract

L'invention porte sur des procédés et des systèmes permettant de conserver un dossier de chaîne de traçabilité pour la manipulation d'un article transféré entre une pluralité d'intervenants. Des modes de réalisation portent sur un système comprenant une pluralité d'ordinateurs pouvant être utilisés par les intervenants. Ce système comporte aussi un formulaire électronique pouvant être transféré entre les ordinateurs. Ce formulaire est transféré d'un ordinateur utilisé par un intervenant vers un ordinateur utilisé par un autre intervenant parallèlement au transfert de l'article du premier au second intervenant. Ledit formulaire permet d'identifier l'article et comprend un espace réservé à l'entrée d'informations par chaque intervenant qui manipule l'article. Les informations entrées par les intervenants comprennent une identification de l'intervenant et une signature numérique de l'intervenant authentifiant l'article. Au moins certaines informations entrées par un intervenant ne peuvent pas être modifiées par un autre intervenant.
PCT/US2005/021328 2004-11-16 2005-06-16 Procédé et système assurant une chaîne de traçabilité électronique Ceased WO2006055046A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10/989,956 US20060106718A1 (en) 2004-11-16 2004-11-16 Electronic chain of custody method and system
US10/989,956 2004-11-16

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WO2006055046A2 true WO2006055046A2 (fr) 2006-05-26
WO2006055046A3 WO2006055046A3 (fr) 2007-04-12

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